Biologics

6 Human Cell, Tissue Donor Eligibility Guides

FDA has published one draft foundation guidance and five immediately effective guidances covering specific disease agents and diseases to assist establishments that make eligibility determinations for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps) to understand the regulations governing donor eligibility. The draft foundation guidance, Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, has general information on determining eligibility for donors of HCT/Ps. It applies to human cells and tissues recovered on or after 5/25/2005, the effective date of the regulations.

When finalized, FDA says, the draft will provide establishments with an updated guidance containing:

updates on current recommendations to appropriately screen and test HCT/P donors for evidence of communicable disease risks;
clarification of recommendations that have been the subject of recurrent inquiries from stakeholders; and
corrections to outdated references, URLs, physical addresses, and FDA contact information.

At the time it is finalized, the foundation guidance with the associated specific guidances will supersede earlier guidances, which will be withdrawn, FDA says.

The associated specific guidances cover:

6 Human Cell, Tissue Donor Eligibility Guides

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